Judge to rule on whether South Lyon pharmacist should lose license over mold

8:05 PM, November 26, 2013

By Tammy Stables Battaglia

Detroit Free Press Staff Writer

A Michigan judge heard hours of testimony today in a case about whether a pharmacist should resume practicing after compounded products from his South Lyon pharmacy were found to be tainted in October.

Pharmacist Kenny Walkup Jr.’s license was suspended and Specialty Medicine Compounding Pharmacy was closed days after mold particles were found in what was supposed to be a sterile dextrose solution the pharmacy mixed and gave to a Henry Ford Health System hospital in October.

The hearing before Michigan Administrative Law Judge David Cohen was still going on early in the evening. The judge was expected to decide whether to reinstate Walkup’s license until a full hearing is held in January.

Today’s testimony focused on the sterility of the South Lyon facility and whether Walkup and the pharmacy were licensed to mix products in bulk.

The pharmacy reported to the FDA that lots of the dextrose product were distributed to hospitals and patients in Michigan between July 1 and Oct. 19. No products were distributed outside of Michigan, according to the pharmacy. The FDA reported in October that it was not aware of any adverse effects to patients.

Assistant Michigan Attorney General Kelly Elizondo argued today that in October 2012, Walkup applied for a manufacturer’s license that would allow him to fill general orders for hospitals or other medical facilities. But when he filled the Henry Ford Hospital order, he was licensed only to fill patient-specific prescriptions, not perform compounding in bulk, she said.

Robert Iwrey, Walkup’s lawyer, says regulations allow pharmacists with his license to provide the service if it’s less than 5% of the pharmacy’s business.

Also during today’s hearing, inspectors for the state and the FDA testified that the pharmacy was not following proper procedures to ensure products were sterile.

Vaughn Hafner, a pharmacy inspector and investigator for the state, testified he saw “flakey, green stuff” in the dextrose solution provided to the Henry Ford facility. When he checked the pharmacy’s records, it didn’t show that Walkup and the pharmacy were testing properly to ensure mixing areas were sterile. Hafner also testified that the pharmacy was testing sterility and effectiveness of medication after 14 days — then allowing for 90-day use on the label.

“It appeared that he was not following good manufacturing practices,” Hafner testified. “In my mind, it constituted a danger to the public.”

Iwrey said the inspectors may have found some faulty practices, but no one proved that the contamination of the dextrose solution discovered in October happened at the pharmacy.

“We don’t know for sure what happened,” Iwrey said. “As we sit here today, no one’s tested my client’s facility, to determine if the mold or fungi occurred (there). …It’s certainly possible that the contamination came from where that pharmacy purchased the active ingredients. No one’s done testing there. It’s possible it occurred at my client’s pharmacy. It’s also possible that it could have occurred at Henry Ford. No one has conclusively proven anything otherwise.”

And although Walkup is selling the assets of the South Lyon pharmacy, he intends to keep practicing, Iwrey said.